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Nuvo Research Announces Successful Completion Of All Pennsaid(R) Studies
Date:1/28/2009

ions in the approvable letter relate to the proposed Pennsaid bottle, the potential interaction of Pennsaid with other topical products and the requirement that Nuvo conduct pre-clinical studies to support the dermal safety of Pennsaid.

Nuvo believes that the completed studies, announced today, support the safety of the Pennsaid bottle, and provide the specific information identified by the FDA as needed to support the safe use of Pennsaid with other topical products. In addition, and as requested by the FDA, Nuvo has completed two pre-clinical repeat dose dermal toxicology studies in animals (the "Dermal Tox Studies"), both of which support Pennsaid's safety.

The FDA previously confirmed in written meeting minutes that a two-year dermal carcinogenicity study in animals (the "Dermal Carcinogenicity Study") could be completed and submitted to the FDA post approval provided that the Dermal Tox Studies did not show signals of safety concern. Nuvo believes that there are no such signals in the Dermal Tox Studies and intends to complete and submit the Dermal Carcinogenicity Study post approval as per its agreement with the FDA.

About Pennsaid

Pennsaid is a topical non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis. Pennsaid allows the active ingredient, diclofenac, to be delivered to a specific site via the surface of the skin and thus limits complications associated with systemic delivery. According to published clinical trials, Pennsaid is as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness associated with osteoarthritis of the knee, as well as improving overall well-being. There are more than 27 million Americans suffering from osteoarthritis, a very painful and debilitating condition, and the United States market for this condition is estimated at US$4 billion annually.

About Nuvo Research Inc.

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SOURCE Nuvo Research Inc.
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